Dynavax Gets 12-1 FDA Vote For Hepatitis B Vaccine

Nasdaq halted Dynavax Technologies Corporation DVAX trading for the entirety of Friday’s session -- both before and after an announcement of regulatory progress for the company’s Hepatitis B vaccine, HEPLISAV-B.

Shortly after 3p.m. ET, it was announced that The Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration voted 12-1 in support of FDA approval.

The vote was based solely on safety, but the panel previously supported the drug’s immunogenicity based on Phase 3 clinical trials.

Hepatitis B currently has no cure, so the medical community emphasizes immunizations to combat the condition.

Existing vaccines are delivered in three doses over six months, and only 54 percent of patients end up completing the course. Dynavax’s vaccine regimen will be more efficient and easier to see through, as it is administered in two doses over one month.

HEPLISAV-B’s Prescription Drug User Fee Act (PDUFA) date is Aug. 10, and if approved, Dynavax intends a commercial launch for early 2018.

The stock closed Thursday's session at $9.25 per share.